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Home » Stakeholders Request Clarity on Particulates in Ophthalmic Drugs Quality Guidance
Stakeholders Request Clarity on Particulates in Ophthalmic Drugs Quality Guidance
Topical ophthalmic drug developers have asked the FDA for greater clarity on evaluating visible particulate matter, extractables and leachables, and petitioned the agency for more specifics on quality issues, as the comment period closed Monday on a revised guidance for such products.